IPEC: Risk Assessment Guide for Excipients now available

The EU Pharmaceutical Legislation Reform: Impact on the API Industry

Recommendation

21 October 2025
Barcelona, Spain

The EU Pharmaceutical Legislation Reform: Impact on the API Industry
An ECA Course prior to the 28th APIC/CEFIC Global GMP & Regulatory API Conference

The new version 1 of the "IPEC Risk Assessment Guide for Pharmaceutical Excipients - Risk Assessment for Excipient Manufacturers (Version 1, 2025)" has just been published on the website of the IPEC (International Pharmaceutical Excipients Council Europe (IPEC Europe)). This guide has been available to IPEC members in the members' area since May 2025 only and can now be accessed under "Resources" in the "Guidelines" section.

The table of contents of version 1 of the new guide published in 2025 includes the following chapters, with chapters 1, 2, and 4 containing further subchapters and subsections. This is an overview of the main chapters:

ACKNOWLEDGEMENTS
1 INTRODUCTION
2 PRINCIPLES OF RISK ASSESSMENT AND MANAGEMENT
3 RISK ASSESSMENT METHODS
4 RISK ASSESSMENT BY EXCIPIENT MANUFACTURER
5 REFERENCES

The full version 1 of the "IPEC Risk Assessment Guide for Pharmaceutical Excipients - Risk Assessment for Excipient Manufacturers (Version 1, 2025)" can be found on the IPEC website.